Efficacy of Fusidic Acid 1% in the Treatment of Bacterial Conjunctivitis

Last updated: July 21, 2025
Sponsor: Baxis Pharmaceuticals, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Eye Disorders/infections

Allergy

Conjunctivitis, Bacterial

Treatment

Fusidic Acid 1%

Placebo

Clinical Study ID

NCT06911424
BXP-301
  • All Genders

Study Summary

The purpose of this clinical trial is to demonstrate the superiority of fusidic acid 1% over placebo in adults and children with confirmed bacterial conjunctivitis and to further establish the safety profile of fusidic acid 1% for topical ocular administration.

Eligibility Criteria

Inclusion

Main Inclusion Criteria:

  • Have a clinical diagnosis of suspected bacterial conjunctivitis in at least 1 eye,confirmed by the presence of purulent or mucopurulent ocular discharge and a grade ≥ 1 on the modified Validated Bulbar Redness (VBR) conjunctival redness scale.

  • Have not received any ocular treatment for conjunctivitis, aside from eyelidhygiene, ≤14 days prior to Visit 1.

  • Have a negative viral conjunctivitis test in both eyes.

  • Agree to discontinue use of eye/eyelid cosmetics during study participation.

  • Agree to discontinue use of contact lenses during study participation.

  • Be willing and able to provide informed consent and comply with the studyrequirements.

  • Not be currently pregnant or breastfeeding. If sexually active, agree to useapproved contraception for the duration of the study.

Exclusion

Main Exclusion Criteria:

  • Have signs and/or symptoms or a diagnosis of fungal, protozoal, or viral etiology ≤30 days prior to Visit 1.

  • Have experienced signs and symptoms of bacterial conjunctivitis for >48 hours priorto Visit 1.

  • Require or are expected to require use of any non-study topical ocular medication orsystemic medications prior to Visit 1 as specified in the protocol as ineligible.

  • Have any abnormality of the ocular anatomy or ocular disease/disorder specified inthe protocol as ineligible.

  • Have a known intolerance, sensitivity or allergy to the study medications or any oftheir components.

  • Have participated in another clinical trial ≤30 days or received anotherexperimental drug ≤90 days prior to Visit 1.

  • Have a family member or household member enrolled in this study.

  • Have a condition which in the investigator's opinion may impact their safety orwould negatively affect the conduct or outcome of the study.

  • Be an employee of or immediate family member of an employee (directly related tostudy conduct) at the study site.

Study Design

Total Participants: 400
Treatment Group(s): 2
Primary Treatment: Fusidic Acid 1%
Phase: 3
Study Start date:
March 21, 2025
Estimated Completion Date:
December 22, 2025

Connect with a study center

  • Baxis Site 04

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • Baxis Site 24

    Huntington Beach, California 92647
    United States

    Active - Recruiting

  • Baxis Site 19

    La Jolla, California 92037
    United States

    Site Not Available

  • Baxis Site 20

    Sherman Oaks, California 91423
    United States

    Active - Recruiting

  • Baxis Site 22

    Doral, Florida 33172
    United States

    Active - Recruiting

  • Baxis Site 11

    Lake Worth, Florida 33460
    United States

    Active - Recruiting

  • Baxis Site 27

    Lutz, Florida 33549
    United States

    Active - Recruiting

  • Baxis Site 01

    Miami, Florida 33155
    United States

    Active - Recruiting

  • Baxis Site 03

    Miami, Florida 33176
    United States

    Terminated

  • Baxis Site 13

    Miami Beach, Florida 33140
    United States

    Active - Recruiting

  • Baxis Site 28

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • Baxis Site 10

    Tampa, Florida 33613
    United States

    Active - Recruiting

  • Baxis Site 15

    Idaho Falls, Idaho 83404
    United States

    Active - Recruiting

  • Baxis Site 06

    Orland Park, Illinois 60462
    United States

    Active - Recruiting

  • Baxis Site 26

    Columbia, Maryland 21045
    United States

    Active - Recruiting

  • Baxis Site 21

    North Las Vegas, Nevada 89030
    United States

    Active - Recruiting

  • Baxis Site 23

    Babylon, New York 11702
    United States

    Active - Recruiting

  • Baxis Site 05

    Mount Airy, North Carolina 27030
    United States

    Active - Recruiting

  • Baxis Site 25

    Tulsa, Oklahoma 74133
    United States

    Active - Recruiting

  • Baxis Site 09

    Pittsburgh, Pennsylvania 15227
    United States

    Site Not Available

  • Baxis Site 12

    Charleston, South Carolina 29414
    United States

    Active - Recruiting

  • Baxis Site 08

    Edinburg, Texas 78539
    United States

    Active - Recruiting

  • Baxis Site 02

    Humble, Texas 77338
    United States

    Active - Recruiting

  • Baxis Site 14

    Kingwood, Texas 77345
    United States

    Active - Recruiting

  • Baxis Site 17

    Layton, Utah 84041
    United States

    Active - Recruiting

  • Baxis Site 18

    Layton, Utah 84041
    United States

    Active - Recruiting

  • Baxis Site 16

    West Valley, Utah 84120
    United States

    Active - Recruiting

  • Baxis Site 16

    West Valley City, Utah 84120
    United States

    Site Not Available

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